These four features are crucial for addressing patient needs and making the product usable and scalable in a variety of healthcare situations. How well these features are implemented can make or break your POC product.
Invetech recently sat down with Dr. Kfir Oved, co-founder, chairman, and former CTO at MeMed, and Dr. Paul Gargan, co-founder and COO at Prominex, to discuss essential elements for success in POC diagnostics. The scope and scale of these companies vary greatly, but the lists of requirements from Dr. Oved and Dr. Gargan were quite similar.
The order of importance may change depending on the business model, but all four conditions are critical for POC success.
“It needs to be a type of information that a physician can actually utilize to better manage the patient, whether it’s a diagnosis, prognosis, or response to treatment. This is key,” said Dr. Oved. “Once you have a good level of confidence that you can provide actionable accurate results, eventually, you need to be accurate enough.”
Dr. Gargan put it this way: “We believe that you can get away with a little bit less accuracy, but it has to be very close to the precision you get from a laboratory or central lab test; otherwise, it’s not going to be accepted.”
However, Dr. Oved noted an important distinction between analytical and clinical accuracy.
“In many cases, people are targeting over-analytical accuracy, which has very little value from a clinical perspective. One of the most important things is to have enough clinical accuracy, not necessarily the highest analytical accuracy,” he said.
2. Turnaround time of minutes, not hours
Users expect POC diagnostics to provide results within minutes instead of the hours or days it takes to get results from a central lab. The exact timing varies based on the use case, but speed is always of the essence.
Prominex’s early market research showed that if doctors in chaotic emergency rooms and clinics didn’t receive results within 10 minutes, they weren’t interested in the device. As such, Prominex aims for a five-minute turnaround, which Dr. Gargan says is the sweet spot for a POC molecular infectious disease platform.
Dr. Oved said this: “If you’re two minutes, like rapid assays, great. If you’re 10 minutes, like our platform, 15 minutes, that’s still fine. If you’re in the two-hour cycle, there is not necessarily enough value for you to bring compared to a central lab workflow.”
3. Easy to use (and maintain)
POC diagnostics users in clinics and hospitals are often not lab experts and don’t have the training or bandwidth to operate and maintain a complicated device. POC solutions must be easy to operate, calibrate, maintain and troubleshoot without sacrificing accuracy.
For all the research and engineering that goes into creating a super smart device on the inside, Dr. Oved says POC diagnostics also have to be super simple on the outside. Ideally, the POC solution provides an intuitive user experience on par with an iPhone.
An effective POC solution also needs to be accessible for patients, which may require a CLIA Waiver.
“We designed our platform to be CLIA Waived so it can be used in non-medical settings — in the workplace, in a pharmacy, in a clinic. It spans out to really put it in places where people can get access,” said Dr. Gargan. He also noted that a product must be incredibly easy to use to be CLIA Waived. To meet that need, Prominex designed a one-step workflow—a feat for complex molecular applications, but necessary for their product’s success.
POC diagnostic solutions often involve complex technology and state-of-the-art interfaces. Although those advancements come at a price, a successful POC diagnostic still must be cost-effective.
Dr. Oved points out that cost-effective doesn’t mean low cost. “You need to make sure you can build a device that can deliver enough value to justify the cost that you’re expecting. If you don’t have a viable business model around that, you better think again about whether you’re building the right platform,” he said.
“Companies must balance the need to be profitable with creating a product that users can afford”
Dr. Gargan pointed out that high-priced molecular POC solutions aren’t sustainable. “When molecular methods first came out, the pricing was 20, 25 dollars. But very quickly, particularly for high-volume testing, that has gone down to single digits. The same thing is going to happen to the point of care.”
Having lived through the nightmare of price pressure in diagnostics, Dr. Gargan shared: “We’ve focused on keeping the design and the manufacturing such that it can withstand the price pressures that will inevitably come.”
Ability to multiplex
Aside from the four requirements for all POC use cases, Dr. Gargan pointed out a specific trait that can be especially desirable for POC infectious disease testing — the ability to multiplex. Products that only detect one condition can have a limited lifespan, but a system that can multiplex lends itself to higher adoption and increased efficiency.
Balancing the must-haves
These four core requirements: actionable results, fast turnaround time, ease of use, and cost-effectiveness are must-haves for POC success.
Dr. Oved summed it up nicely with this: “I think a Point of Care platform is always suffering from this two-edged sword. On one hand, it needs to provide results that are always expected to be as good as a central lab instrumentation. So you’re always trying to balance between what’s most important—which is the clinical accuracy of what you’re doing—compared to how to build this platform in a way that will be scalable, cost effective, relatively free of failures and calibration processes and other types of issues that are more acceptable at the central lab and much less acceptable at the point of care.”
Even with the difficult balancing act, integrating these four features into a POC diagnostic solution can put your product on the path to success. To learn more on how to create a successful POC diagnostic, watch the full webinar.
For a deeper dive into these topics, be sure to download our Design Guide for creating a differentiated platform. It’s loaded with actionable insights on many of the themes discussed by the panelists, including delivering a great user experience and minimizing total cost of ownership for your POC product.
Design Guide for Creating a Differentiated Point of Care Diagnostics Platform
Discover practical strategies for bringing unique, profitable POC platforms to market. Download the full guide.